Methods and Devices for Cleaning and Sterilization with Shock Waves

ABSTRACT

Shock waves are applied to clean and sterilize fluids in containers and conveyances. Shock waves destroy pathogens and pollutants in blood, water, food liquids and other fluids.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of U.S. patent application Ser.No. 12/884,511 filed Sep. 17, 2010, which claims the benefit of priorityof U.S. Provisional Application No. 61/243,426 filed Sep. 17, 2009,which are incorporated herein by reference.

BACKGROUND

When extracorporeal lithotripsy was developed and used for the treatmentof kidney stones, it was observed that the pressure shock waves may havean anti-bacterial effect. Some of the kidney stones incorporate bacteriain them (due to their bacterial etiology) and after stone fragmentation,a higher rate of infection was expected, at least until the stonefragments were passed naturally. That was not the case when lithotripsypressure shock waves were used, which pointed out toward bactericidaleffect of the pressure shock waves. The same bactericidal phenomenon wasobserved during wound treatment using pressure shock waves.

The above-mentioned observations triggered extensive pre-clinicalstudies using laboratory cell cultures or animals. These studies showedthat pressure shock waves can destroy, reduce proliferation of mostcommon Gram positive and Gram negative, aerobic and anaerobic bacteriaor break bacterial biofilms. The targeted bacteria includedStaphylococcus aureus, Methycillin-resistant Staphylococcus aureus(MRSA), Streptococcus mutans, Actinomyces naeslundii, Porphyromonasgingivalis and Fusobacterium nucleateum.

The killing of bacteria is suggested to result from a combination of thefollowing mechanisms:

-   -   strong mechanical forces generated by pressure shock waves that        can disrupt biofilms;    -   cavitation microjets generated by collapsing cavitation bubbles        can kill bacteria or disrupt biofilms;    -   localized thermal effects produced by collapsing cavitation        bubbles can also kill bacteria; and    -   shock waves generated free radicals can have a destructive        effect on bacteria or biofilms.

A similar effect as the one observed for bacteria was also shown inviruses. Based on preclinical studies, it is suggested that pressureshock waves can disrupt the outer membrane of the viruses and thebacteria that hosts the virus and thus killing them.

Another important observation from prior studies is that the membrane ofthe viruses and bacteria seems to be less flexible when compared withnormal tissue cells or fluidic cells (as red blood cells), which makesbacteria and viruses more prone for destruction by the combinedmechanisms generated by the pressure shock waves (compressive pressurescombined with high velocity cavitation microjets).

Based on the above observations, a need exists to adapt the use ofpressure shock waves in order to eliminate bacteria from fluids or fromsolid networks that might be filled with fluids. Further, a need existsto similarly use shock waves to disrupt viruses (immunodeficiencyvirus—HIV, hepatitis viruses, papilloma virus, herpes simplex virus,etc.) and to kill different micro-organisms such as giardia lamblia,legionella, cryptosporidium, and the like.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic diagram of containers of blood in a shockwavetreatment system in one embodiment of the present invention.

FIG. 2 is a schematic diagram of an ellipsoidal reflector and shock wavefocal volume in one embodiment of the present invention.

FIG. 3A is a top cross-sectional schematic diagram depicting multiplefocal volumes from multiple shock wave applicators to a container in oneembodiment of the present invention.

FIG. 3B is a top perspective view from above of a container in oneembodiment of the present invention.

FIG. 4 is a schematic diagram of ellipsoidal shock wave reflectorgeometry and its focal points in one embodiment of the presentinvention.

FIG. 5 is a cross-sectional schematic diagram of ellipsoidal shock wavereflector geometry that generates unfocused shock waves in oneembodiment of the present invention.

FIG. 6A is a schematic diagram depicting the angular positioning ofmultiple shock wave applicators along multiple segments of a pipe in oneembodiment of the present invention.

FIG. 6B is a schematic diagram depicting the actual positioning ofmultiple shock wave applicators along multiple segments of a pipe in oneembodiment of the present invention.

FIG. 7 is a cross-sectional schematic diagram of multiple shock waveapplicators along a funnel device in one embodiment of the presentinvention.

FIG. 8 is a top cross-sectional schematic diagram of circumferentialfluid tube and rotatable shock wave applicators in one embodiment of thepresent invention.

FIG. 9 is a cross-sectional plan view of a circumferential fluid tube inone embodiment of the present invention.

FIG. 10 is a cross-sectional schematic diagram of multiple rotatablecircumferential tubes and stationary central shock wave applicators inone embodiment of the present invention.

FIG. 11 is a cross-sectional schematic diagram of full ellipsoidalreflector with the upper shell of a shock wave device including a bag offluid to be treated in one embodiment of the present invention.

FIG. 12A is a cross-sectional schematic diagram of ellipsoidal reflectorof an electrohydraulic shock wave device with a bag-contacting surfacein one embodiment of the present invention.

FIG. 12B is a cross-sectional schematic diagram of ellipsoidal reflectorof a piezoelectric shock wave device with a bag-contacting surface inone embodiment of the present invention.

FIG. 13 is a cross-sectional schematic diagram of an electromagneticshock wave device with unfocused waves delivered to a bag of fluid inone embodiment of the present invention.

FIG. 14 is a cross-sectional schematic diagram of a shock waveapplication system that targets a tissue sample suspended in a bath inone embodiment of the present invention.

FIG. 15 is a schematic diagram of a movable shock wave applicator andmovement path across a tissue in one embodiment of the presentinvention.

FIG. 16A is a cross-sectional schematic diagram of an electrohydraulicshock wave device with a meat moving mechanism in one embodiment of thepresent invention.

FIG. 16B is a schematic diagram of a meat moving mechanism in oneembodiment of the present invention.

FIG. 17 is a schematic diagram of multiple shock wave applicatorspositioned along an industrial fluid filtration pipe in one embodimentof the present invention.

FIG. 18 is a top cross-sectional top schematic diagram of a rotatableshock wave applicators' wheel positioned around a filtration pipe in oneembodiment of the present invention.

FIG. 19 is a cross-sectional schematic diagram of a vertical battery ofshock wave applicators' wheels' along a filtration pipe in oneembodiment of the present invention.

FIG. 20 is a schematic diagram of tubular shock wave reflectorsincluding multiple electrodes positioned along a filtration pipe in oneembodiment of the present invention.

FIG. 21 is schematic diagram of a series of shock wave applicators in avalve-controlled piped fluid treatment system in one embodiment of thepresent invention.

DESCRIPTION OF THE INVENTION Blood Cleaning/Sterilization

Blood is an important human body fluid and is required for transfusionsduring medical interventions or for treating different diseases relatedto blood. The fact that blood goes everywhere in the body to bringnutrients to the living tissue makes it a very important part of thehuman/animal body. The blood can sustain life or bring bacteria andviruses and thus infection to organs/tissue/cells. This is why a healthyblood is vital for a healthy human/animal or to treat differentdiseases, infections that might affect human or animal bodies.

For medical purposes, blood is usually collected from healthyindividuals, stored in plastic containers and administered as neededduring medical procedures. Healthy volunteers/donors have to passextensive background check and then the collected blood is tested fordifferent pathogens that might be transmitted through blood. Thecollected blood, as of today, cannot be sterilized with existingcleaning/sterilization methods, due to their negative impact on blood.Thus radiation is not recommended, chemical cleaning/sterilization thesame, and heat methods can coagulate the blood, which is not desired,etc. Accordingly, a method that can be used to sterilize the blood is animportant need to allow the building of a larger blood supply forhospitals or to use for auto-transfusions (use the patient's own bloodafter cleaning/sterilization) for individuals that need blood to treattheir afflictions.

The utilization of pressure shock waves to destroy pathogens, such asbacteria, viruses and other micro-organisms, is described in differentmethod and design embodiments for eliminating contaminants from blood.In some embodiments, a method of the invention can be applied withoutphysical contact with the blood and without destructive effects ondesired blood components (leukocytes, lymphocytes, red blood cells, andplatelets).

In methods of the invention, pressure shock waves can be produced usingelectrohydraulic, piezoelectric, electromagnetic, or blast pressureprinciples. Also, the pressure shock waves can be focused, unfocused,planar, pseudo-planar or radial. The pressure shock waves should have ahigh compressive phase followed by a strong tensile phase that producessignificant cavitation. The high velocity cavitation microjets generatedduring collapse of the cavitation bubbles play an important role inpermanently breaching the membrane of the bacteria and viruses and thusdestroying them.

In various embodiments, the blood moves through sterilecontainers/pipes/tubes in close association with a shock wave source. Inother embodiments containers or bags filled with blood can be exposed topressure shock waves by moving the pressure shock waves applicatoraround the container/bag.

Embodiments to produce blood cleaning/sterilization are furtherdescribed. It will be appreciated that in other embodiments differentfluids may be similarly treated.

Referring to FIG. 1, blood containers 1 to 18 sit on a conveyer-typeadvancing system that moves in front of the pressure shock waveapplicators 20, as indicated by the arrow. In the embodiment of FIG. 1six (6) applicators 20 are used. The total number of applicators 20 maybe selected by the desired productivity of the system. In an exemplaryembodiment at least four (4) applicators 20 are provided.

As shown in FIG. 1, containers 1, 4, 7, 10, 13 and 16 are treatedsimultaneously by six applicators 20 in one position of the conveyerbelt. After the cleaning/sterilization process is finished forcontainers 1, 4, 7, 10, 13 and 16, the conveyer belt moves with adistance equal with the diametric dimension of a containers (containers1 to 18 have the same diametric dimension) and in this new position thesystem sterilizes the blood from containers 2, 5, 8, 11, 14 and 17.After enough pressure shock waves were delivered to containers 2, 5, 8,11, 14 and 17, the conveyer moves again to align containers 3, 6, 9, 12,15 and 18 with the corresponding applicators 20. Finally, after thecomplete cycle of cleaning/sterilization is applied to containers 3, 6,9, 12, 15 and 18, the conveyer belt moves with a distance equal with afresh batch series of eighteen (18) containers that will be treated in asimilar manner as described above by the battery of applicators 20.Utilizing the above described sequence, the cleaning/sterilization ofthe blood is produced in an efficient manner. In embodiments, deliveredshock waves are generated from 250 to 2,000 pulses/cm³ of blood, with 5kV-30 kV high voltage per discharge, with frequencies higher than 1 Hzand generating energies in the targeted area higher than 0.05 mJ/mm² andless than 0.9 mJ/mm²).

The total number of applicators 20 used in a battery and the number ofthe containers 1 that can be used on the conveyer belt depends on thecapacity of the cleaning/sterilization line and desired efficiency toassure an economical way to clean/sterilize the blood. Also, thearrangement presented in FIG. 1 can include computerized control ofconveyer belt movement and timing of cleaning/sterilization for eachcontainer (1 to 18), including based on the type of contaminant orcontaminants that is/are targeted during cleaning/sterilization process.Computer control provides flexibility for the wholecleaning/sterilization line. It will be appreciated that timing for thecleaning/sterilization chosen for a certain process is the largest timenecessary to kill a certain contaminant (bacteria or virus) when thecleaning/sterilization process is targeting multiple contaminants. Theselection of timing can be done automatically based on a selection menuincluded in the user interface of a software program that is running thecleaning/sterilization process.

The blood containers' (1 to 18) dimensions may be provided in such wayto be completely encompassed within the dimensions of the focal volumeof the pressure shock wave applicators 20, thereby allowing a completeflooding with high energy pressure shock waves of the entire container(1 to 18). The focal volume 25 is defined as the volume (cigar shape) inwhich the highest pressure gradients and energy concentrations areproduced due to the shock waves focusing process (as can be seen in FIG.2), when using a focusing reflector 22 that can be ellipsoidal,parabolic, spherical, etc., in shape (the reflector 22 is the main partof the applicators 20 construction). In FIG. 2 is presented anellipsoidal reflector 22 that has its main characteristics defined byits major and minor elliptical semiaxes values. The ratio of the majorsemiaxis and minor semiaxis (c/b) dictates the dimensions of the focalvolume 25. If the value of the ratio is closer to 1 the reflector 22will generate almost a spherical focal volume 25 and the larger theratio is (2 or higher) the reflector 22 will generate a broader andlonger focal volume 25 (generally a cigar shape focal volume 25). Also,the focal volume 25 can become broader and longer with the decrease ofreflector 22 diametric opening at its mouth (called also aperture). Ingeneral, the amount of energy deposited in the focal volume 25 isdependent on the surface area used by reflector 22 for focusing thepressure shock waves (the deeper reflectors 22 can generate more energywhen compare with shallower reflectors 22).

The energy input settings (process values) can also influence the focalvolume 25 dimensions used for the embodiment presented in FIG. 1. Thehigher the settings for the shock waves the larger the focal volume 25can be. Therefore, based on the geometrical dimensions and materialsused in construction of the pressure shock waves reflectors 22, on thetype of shock wave source used (electrohydraulic, electromagnetic,piezoelectric, or blast) or on the energy input settings, the dimensionsof the containers (1 to 18, as presented in FIG. 1) can be determinedbased on the desired applicators' 20 and reflectors' 22 dimensions andtargeted utilization. Different geometries and different methods toproduce pressure shock waves will provide different focal volumes 25. Ingeneral, the larger the dimension of the focal volume 25, the moreefficiency is achieved.

For example, if the focal volume 25 is approximated to Ø10×20 mm³(cylinder with 10 mm diameter and 20 mm in length/height), the bloodcontainers (1 to 18) should have the same volume or smaller. Thesecontainers (1 to 18) are positioned on the respective designated slotsof the conveyer. Then the conveyer brings them in front of theapplicators 20 that will use pressure shock waves to kill contaminantsfrom the blood.

Similar effects can be obtained if the blood is circulated at a veryslow speed in front of the pressure shock wave applicators 20. Inalternative embodiments to containers 1, a continuous pipe full of bloodcan be used for circulating the blood in front of the shock waveapplicators 20. In this embodiment, the diameter of the pipe shouldmatch the smaller dimension of the focal volume 25 for the applicators20 (for example if the focal volume 25 has a length of 20 mm and adiameter of 10 mm, then the dimension of the pipe for blood circulationshould be diameter of 10 mm).

Referring to FIG. 3A, in an embodiment a blood container 1 made of aplastic that has acoustic impedance close to the water or blood isprovided. In this embodiment, the container 1 is a cylinder of a largerdimension, due to the fact that the treatment container 1 is placed inan area where multiple focal volumes (25A, 25B, 25C and 25D produced bythe corresponding applicators 20A, 20B, 20C and 20D) are intersecting.For example with a focal volume 25 of 20 mm in length and 10 mm indiameter, the container 1 could have a diameter “D” of 40 mm and a width“W” of 8-10 mm (see FIG. 3B). To sterilize the blood, the applicators20A, 20B, 20C and 20D from FIG. 3A can be fired simultaneously orsequentially and the container 1 has a rotational movement in front ofthe applicators 20A, 20B, 20C and 20D (as seen in FIGS. 3A and 3B).

To increase the focal volume 25 in the cleaning/sterilization area, andthus the volume of the blood containers 1, the ratio of the major andminor semi axes of the ellipsoid (c/b) can be increased, which will givean increase of the ellipsoid geometry and generally an increase in thereflector 22 area for the device, as shown in FIG. 4. A deeper reflector22 (larger major semi axis c) will generally provide a longer and widerfocal volume 25 and an increase in the minor semi axis “b” will give adecrease in the diameter and length of the focal volume 25. FIG. 4 alsoshows that the ellipsoidal geometry is characterized by the first focalpoint F₁ as the origination of the pressure shock waves and by thesecond focal point F₂ as the point where the focusing is targeted. F₁ inembodiments resides inside the reflector 22 of the applicator 20 and F₂can in various embodiments be positioned before, in or after thetargeted area for pressure shock waves treatment. In order to positionthe second focal point F₂ before, in or after targeted area for pressureshock waves treatment, only a portion of the ellipsoidal geometry isnecessary in embodiments for focusing, such as half of the ellipsoidalgeometry.

Another method to increase the volume used for cleaning/sterilization isthe use of unfocused devices (they do not have a defined focal volume 25unlike focused devices), as presented in FIG. 5. In this embodiment thecleaning/sterilization is produced through high pressure gradientsproduced by the partial focusing and distortion of the spherical wavesgenerated in F₁ (first focal point for the ellipsoidal geometrypresented in FIGS. 4 and 5). These pressure gradients are found in thearea where the blood containers 1 are placed for cleaning/sterilization.

Another option is given by pressure waves generated by radial devices.With the radial devices a field of high pressure is created thatdissipates rapidly from the source inside the blood container 1. In thisembodiment, there is generally no focal volume 25 present andalternatively a field of high pressure gradients is created in thetreatment/cleaning/sterilization area, as described before for theunfocused devices, which creates pressure waves and not shock waves(shock waves are characterized by strong temporal and peak pressuredistortions between the compressive and tensile portion of the wave).The high pressure gradient fields generated by unfocused or radialpressure waves can be also used for the embodiments presented in FIG. 1and FIGS. 3A and 3B, which can significantly increase the size of thecontainers 1, an in embodiments the efficiency of the treatment.

In different embodiments, there is a tuning of the pressure valuesneeded to kill different types of bacteria, viruses, and microorganisms,which will dictate the approach for a specific treatment (focused,explosive, unfocused or radial pressure waves). Multiple stations ofpressure shock waves devices can be set for treating the same batch ofblood containers 1 so that each station or individual device is tuned upfor different pressure values that have specific action on a specifictargeted type(s) of pathogen(s), to accomplish a desirablecleaning/sterilization of the blood.

The cleaning/sterilization of the blood can be applied to the wholeblood (e.g. prior to any filtration) or to blood components after afiltration process or processes. The number of pulses delivered, energysetting and frequency of shock delivery (number of pulses per second)can be adjusted for the specific situation. For example, atreatment/cleaning/sterilization regiment may be applied differently andspecifically for: whole blood, red blood cells, platelets; and serum.

It will be appreciated that specific parameters and methods applicableto specific components of blood (or other fluids) may be utilized in thevarious embodiments that are presented in this disclosure. Further, insome embodiments, specific targeted microorganisms, bacteria and virusesin the blood may be treated with shock waves under specific parametersindividually more effective to the particular target.

In some embodiments, to eliminate residues of bacteria, viruses, DNAfragments and cells that did not survived the cleaning/sterilizationprogression, a filtration process after cleaning/sterilization may beused.

In other embodiments, the cleaning and sterilization process can bedesigned to use small and portable treatment units that can be utilizedfor field transfusions, such as in geographical areas of difficultaccess of for emergency medical purposes (e.g. military, disasterareas). These devices can be alternatively driven by connection toavailable energy sources or by batteries (rechargeable ornon-rechargeable).

Another arrangement for blood cleaning/sterilization, designed toincrease efficiency is presented in the embodiment of FIGS. 6A and 6B.

FIG. 6A shows a sequence of blood containers 1 to 8 arranged end to endin a conveyor (such as similar to FIG. 1). In other embodiments thecontainers may alternatively be individual segments of a cylindricalpipe, and the individual views show an exemplary way to dispose shockwave applicators 20A, 20B, 20C, 20D, 20E, 20F, 20G and 20H in a 3D(spatial) manner (indicated by the direction of the arrows around theindividual blood segments/containers 1 to 8) to produce optimumcleaning/sterilization of blood flowing through the cylindrical pipe orconveyed in containers 1 to 8. Such arrangement provides a highlyefficient blood cleaning/sterilization process in embodiments of theinvention. FIG. 6B depicts physical disposition around the pipe/conveyerof the applicators 20A, 20B, 20C and 20D (the applicators 20E, 20F, 20Gand 20H are not shown). In embodiments the individualsegments/containers 1 to 8 have dimensions comparable with the focalvolumes 25 (not shown in FIG. 6B) produced by the applicators 20A, 20B,20C, 20D, 20E, 20F, 20G and 20H. Also, the actual dimensions of theapplicators 20A, 20B, 20C, 20D, 20E, 20F, 20G and 20H should allow themto be positioned with at least 90° angle intervals around the pipe andwith an axial step equal with the length of each segments/containers 1to 8.

The embodiment presented in FIGS. 6A and 6B (with containers) includes aforward movement/indentation for eight (8) sequential containers 1 to 8(equal with the diametric dimension of the focal volume 25 of theapplicators 20A, 20B, 20C, 20D, 20E, 20F, 20G and 20H) in one stepcompared with the previous embodiment presented in FIG. 1, whichincludes a forward movement for only one diametric dimension of thefocal volume 25 for the first three (3) steps and then a fourth movementequal with 18 times the diametric dimension of the focal volume 25 forthe 1 to 18 blood containers sterilized in the first three steps. The 4(four) steps presented for solution from FIG. 1 will produce for theembodiment described in FIGS. 6A and 6B the cleaning/sterilization of 32blood containers. The embodiment of FIGS. 6A and 6B uses 8 pressureshock waves applicators/heads, which means that if the same number ofapplicators/heads (8) are used in the embodiment of FIG. 1 the totalnumber of containers sterilized in four (4) sequential steps is 24compared with 32 for the embodiment FIGS. 6A and 6B, i.e. a 25% increasein efficiency.

Both embodiments presented in FIGS. 1 and 6A and 6B can also usecontinuous flow of blood through a pipe in front of the pressure shockwaves applicators 20A to 20H, with a correct timing to the presence ofblood in the targeted area to avoid under or over exposure to thepressure shock waves.

For the embodiment presented in FIG. 7, the untreated blood is droppedin a funnel container 70 that goes in front of four (4) applicators 20A,20B, 20C and 20D arranged symmetrically around the funnel container 70,to allow the overlap of their focal volumes. The overlap of focalvolumes creates a targeted/treatment volume 75 in the funnel container70 in between the two valves 71 and 72 (71 is identified as top valve ofthe funnel container 70 and 72 as the lower valve of the funnelcontainer 70).

The targeted/treatment volume 75 enclosed in between valves 71 and 72 isa region where the combination of the focusing created by applicators20A, 20B, 20C and 20D will generate an increased amount of energy thatcan be able to kill the most resistant bacteria, viruses ormicro-organisms, due to overlap of individual focal volumes 25A, 25B,25C and 25D (not specifically identified in FIG. 7).

In this embodiment the cleaning/sterilization process has the followingsteps:

-   -   1) with valves 71 and 72 closed the blood is placed in the upper        funnel container 70    -   2) valve 72 stays closed and valve 71 is opened, which allows        the blood to get in the designated targeted/treatment volume 75    -   3) valve 71 is closed and the cleaning/sterilization process is        done to the designated targeted/treatment volume 75, by the        applicators 20A, 20B, 20C and 20D    -   4) after the cleaning/sterilization is finished, valve 72 is        opened, which allows the sterilized blood to go in the        collection bag/container 78    -   5) valve 72 is then closed after the blood emptied the        designated targeted/treatment volume 75    -   6) repeat steps 2 to 5 until the whole quantity of blood that        can be received by the collection bag/container 78 is        sterilized. After the collection bag/container 78 is filled in,        it can be replaced by a new/empty collection bag/container 78.        The replacement of the collection bags/containers 78 must be        done all the time with the valve 72 in closed position.

In the embodiment presented in FIG. 8 the circumferential blood/fluidtube 80 is fixed and the applicators 20A, 20B, 20C and 20D are mountedon an applicators' rotator 85, which allows the rotational movement(indicated by the arrow) of the applicators 20A, 20B, 20C and 20D toproduce the necessary treatment/cleaning/sterilization of the blood. Inthis way the focal volumes 25A, 25B, 25C and 25D (produced by theapplicators 20A, 20B, 20C and 20D) are moved along the circumferentialblood/fluid tube 80 with a predetermined speed to allow completeexposure of the blood to the pressure shock waves and thus the completecleaning/sterilization of the blood enclosed in the circumferentialblood/fluid tube 80 is done. After cleaning/sterilization cycle thecircumferential blood/fluid tube 80 is removed from the fixture and anew one is attached for a new cleaning/sterilization cycle. This method,as in the previous embodiments, can be fully automated using robotic andcomputerized systems to increase productivity and provide adaptabilityto the specific pathogen or pathogens targeted by the bloodcleaning/sterilization cycle.

Referring to FIG. 9, the cross section of the circumferentialblood/fluid tube 80 is shown to mimic the focal volumes 25A, 25B, 25C or25D in size and shape.

In the embodiment shown in FIG. 10, multiple applicators 20 are attachedon fixed mounting structure 106 and the circumferential blood/fluidtubes 80 have a motorized circumferential movement around theapplicators 20, via a gear mechanism 102, which is driven by the rotatormotor 104. Also, FIG. 10 shows three applicators 20 and circumferentialblood/fluid tubes 80 that form stations in a vertical stackingconstruction, for improved efficiency. In this embodiment, the movementof the circumferential blood/fluid tubes 80 in front of the applicators20 is done with a predetermined speed to allow complete exposure of theblood to the pressure shock waves and thus desirablecleaning/sterilization of the blood enclosed in the circumferentialblood/fluid tubes 80 is accomplished.

This arrangement can be also fully automated using robotic andcomputerized systems to increase productivity and provide adaptabilityto the specific pathogen or pathogens targeted by the bloodcleaning/sterilization cycle.

FIG. 11 shows another embodiment with a blood bag in a shock waveapplicator device that can be used for blood cleaning/sterilization.With further reference to FIGS. 12A and 12B electrohydraulic andpiezoelectric principles used to produce pressure shock waves are shownas well-suited to the bag-treatment embodiment of FIG. 11.

In the embodiment of FIG. 11 the upper shell 115 of an ellipsoidgeometry is used to create a full ellipsoid together with the reflector22, which allows the usage of the whole surface of the ellipsoid forfocusing the pressure shock waves. In this way a field of pressuregradients is created in the whole volume of the ellipsoid, which inprinciple doubles the efficiency compared with classical construction ofreflectors 22, which use only 50% of an ellipsoid surface to focuspressure shock waves (they represent half an ellipsoid). With suchapproach, the volume of blood sterilized in one session is thusincreased and the cleaning/sterilization process is produced in ashorter period of time compared with methods and constructions describedin other embodiments.

The upper shell 115 and the reflector 22 are kept together using thelocking/latching devices 117. The focusing can still be generated withthis embodiment, although on the way to the focus the pressure gradientsgenerated during focusing process inside the ellipsoid are high enoughto themselves kill bacteria/viruses. The milder pressure gradientsgenerated in such embodiment, when compared with the pressure valuesfrom the focal volume 25, provide a milder option to kill bacteria,viruses or micro-organisms.

In order to produce the pressure shock waves for the electrohydraulicembodiment presented in FIG. 11, the pressure shock waves will originatefrom F₁ where a high voltage discharge in water/propagation medium 112is produced in between two opposing electrodes 110. Thewater/propagation medium 112 volume is contained in between the bottomof the reflector 22 and the membrane 114. The membrane 114 is also usedto isolate the water/propagation medium 112 from thecleaning/sterilization zone. The volume of the blood bag 119 can matchthe volume of the actual cleaning/sterilization zone, for maximumefficiency. Due to the presence of the membrane 114 in order to allow agood propagation of the shock waves from the water/propagation medium112 through the membrane 114 and into the blood bag 119, a good couplingmust be accomplished in between the membrane 114 and the blood bag 119by using a coupling ultrasound gel. As shown in FIG. 11, the blood bag119 sits on top of the membrane 114 where a coupling gel is applied inembodiments. The gel may also applied to the coupling between the bloodbag 119 and the upper shell 115 of the ellipsoid.

The same coupling principle applies to all the coupling surfaces betweendifferent components presented in embodiments from this patent. Thus thecomponents that are intersected by the propagating pressure shock wavesmust use a coupling substance in order to avoid diffraction andreflection of the shock waves, or the loss of energy at the boundariesbetween different substances/materials of very different acousticimpedance (for example water and air have very different acousticimpedances and this is why this mismatch must be avoided during pressureshock waves propagation).

An important feature of the same embodiment presented in FIG. 11 isgiven by the fact that the pressure gradient creates a movement(stirring effect) inside the bag, resulting in homogeneous treatment ofthe whole volume blood bag 119.

A piezoelectric embodiment (as presented in FIG. 12B) will not need thewater/propagation medium 112 reservoir and the membrane 114, aspresented in the electrohydraulic embodiment of FIGS. 11 and 12A.However, the blood bag/container coupling surface 120 of the reflector22 is still present in both electrohydraulic reflector 22 (presented inFIG. 12A) or for the piezoelectric reflector 22 presented in FIG. 12B.

The piezoelectric embodiment of FIG. 12B provides more space for theblood bag 119, which now can fill completely the bottom portion of thereflector 22. This is possible because the piezoelectric elements 126can be disposed on the surface of the reflector 22 and thus the pressureshock waves emanate directly from the reflector 22 surface, without theneed of a dedicated space for a spark discharge in between two opposingelectrodes 110, as presented in FIG. 11.

In another embodiment shown in FIG. 13, pressure shock waves producedusing the electromagnetic principle and an unfocused approach may beused to treat blood bag 119.

Cleaning/sterilization in this embodiment is induced by pressuregradients, without any focusing or focal volume 25 presence. The lens132 forms a separation between the upper chamber, where the blood bag119 is found inside the upper shell 115, and the lower chamber formed inbetween the lens 132, lower shell 116 and the electromagnetic wavetransmitter/piston 136. The upper shell 115 and the lower shell 116 arekept together using the locking/latching devices 117. Theelectromagnetic planar waves 30 are generated inside the lower shell 116by the electromagnetic coil/trigger 135 that makes the electromagneticwave transmitter 136 to vibrate in the vertical direction due to themovement of the blasting piston 137 when a current is passed through theelectromagnetic coil/trigger 135. The lens 132 collects the planar waves30 generated in the lower chamber and then distribute them (still in aplanar form) into the blood bag 119.

Cleaning of Harvested Human and Animal Tissue for Implantation

The cleaning/sterilization effect of pressure shock waves can be usedfor human or animal tissue that was harvested for human implantation.This harvested tissue needs to be cleaned of any contaminants (bacteria,viruses, micro-organisms, etc.) in order to avoid any immune reactionfor the recipient.

Such tissues may include, for example, soft tissue (e.g. skin, tendons,ligaments, etc.); or hard tissue (e.g. bone, cartilage, etc.).

The pressure shock waves applied to the harvested tissue can help toclean the scaffolding (collagen matrix, bone matrix) out of unwantedgerms brought into the tissue by the blood circulation.

When the harvested tissue has a small size, it can be suspended in asaline bath (or any other fluid that it is used in the cleaning andprocessing of the tissue) and treated in a fixed position without theneed to move the sample around in the field targeted by the pressureshock waves, as shown in FIG. 14.

This embodiment is practical only when the dimensions of the tissue 140are comparable with the dimensions of the focal volume 25. The tissuecan be suspended directly in the saline or using a special designedbasket, which will not interfere with the shock wave propagation.

As shown in FIG. 14, on top of the reflector 22 a membrane 114 is usedto create an enclosed chamber in which the high voltage discharge of theopposing electrodes 110 is produced inside the water/propagation medium112 in order to generate electrohydraulic pressure shock waves. Themembrane 114 is also used to create the coupling of the reflector 22with the holding vessel 145 in which the cleaning is made. The materialof the membrane 114 allows the good propagation of the pressure shockwaves from the reflector 22 to the fluid/saline 147 that fills theholding vessel 145 and surrounds the tissue 140. The correct positioningof the tissue 140 relatively to the focal volume 25 of the reflector 22is realized via the tissue support fixture 148.

In general for cleaning/sterilization of the human or animal tissue thatwas harvested for human implantation is desired to obtain energies inthe treatment area between 0.10 and 1.20 mJ/mm² and use frequencies ofpulses per second between 1 Hz and 12 Hz. The energy necessary to treatthe tissue sample is dependent on the type of tissue that iscleaned/sterilized. A high energy setting (energy flux density between0.40 and 0.90 mJ/mm²) combined with high number of pulses (higher than1,000 pulses/cm³) is used in various embodiments for hard tissuecleaning. Lower energy settings (energy flux density between 0.10 and0.40 mJ/mm²) and lower number of shocks/pulses (50 to 500 pulses/cm³) isused in various embodiments for soft tissue cleaning. In certainembodiments, different settings (energy level, number of shocks/pulses,and frequency of the shocks/pulses) may be applicable to a specific hardor soft tissue, or to different respective portions of a particulartissue, to achieve desirable cleaning

Referring to FIG. 15, in the case of a tissue that has a larger volume,the cleaning process in certain embodiments includes the movement of theapplicator 20 and reflector 22 with its associated focal volume 25 alongthe tissue surface to allow the cleaning of the whole tissue sample 140.

The movement can be done manually or automatically by a controlleractuated by a software program, on an applicator movement path/pattern155 between the applicator starting position 150 and applicator endingposition 159.

If the thickness of the tissue sample is higher than the length of thefocal volume, the harvested tissue can be treated on both sides with thesame movement of the applicator 20 and reflector 22 with its associatedfocal volume 25 along both tissue surfaces to allow the cleaning of thewhole tissue sample 140. The movements can be done manually orautomatically by a controller actuated by a software program.

Cleaning/Tenderizing of Animal Meat

Pressure shock waves can also be used in embodiments of the invention toclean germs or micro-organisms from animal meat. Using a set-up asgenerally described in FIGS. 14 and 15, the meat can be concomitantly orsequentially cleaned and/or tenderized in a short period of time, whichis very important for prime cuts. Using the pressure shock wave fortenderizing it can be avoided to keep the meat refrigerated forprolonged time intervals (days to weeks) in specialized rooms fortenderizing, which can reduce the expenses (energy and capital costs)associated with such prime cuts. Scientific literature has reportedsuccessful results in tenderizing the meats using specific blastingpressure shock waves. This technique has significant drawbacks (use ofdangerous explosive devices, large and very strong containers to containexplosions, etc.) that can be eliminated by using electrohydraulicgenerated pressure shock waves.

The usage of pressure shock waves for cleaning animal meat from germs ormicro-organisms and/or tenderizing using an electrohydraulic device ispresented in one embodiment in FIGS. 16A and 16B. Set-ups similar to theelectrohydraulic devices can be created using electromagnetic orpiezoelectric (using piezoelectric crystals or fibers) technologies.

The pressure shock waves generated using these principles(electrohydraulic, electromagnetic or piezoelectric) generate lowerpressure gradients when compared to the blast pressure shock wavesdescribed in prior art uses. To put the same amount of energy in thetarget as the blast pressure shock waves, in the case of usingelectrohydraulic, electromagnetic or piezoelectric generators a largernumber of shocks are applied (between 24 to 500 pulses per cm³ of meat)and with energies delivered in the targeted area of 0.20 to 0.80 mJ/mm².By comparison, the blast pressure shock waves are radial in nature(unfocused) which means that the highest pressure is found near thesource and the energy fades away when the pressure shock waves increasetheir distance from the source, which gives an exponential decay of thepressures inside the targeted volume. Focused shock wave devices cancontrol the treatment region and can generate very high pressures in thefocal volume 25 and thus provide high energies into the target.

For both cleaning and/or tenderizing processes, meat 160 can be sealedin vacuum bags and then placed inside the treatment tank 162 filled withfluid/water 164, as shown in FIG. 16A. The pressure shock waves 167 aregenerated by the high voltage discharge in between the opposingelectrodes 110, found at the bottom of the reflector 22 that is used toreflect and focus the pressure shock waves 167 towards the vacuum bagwith meat 160 placed inside the treatment tank 162. The transmission ofthe shock waves without attenuation is done via the water/propagationmedium 112 and tank fluid/water 164 in which the vacuum bag with meat160 was placed.

To move the vacuum bag with meat 160 in the focal zone of the shock wavedevice, a two-dimensional moving mechanism 165 can be employed, as shownin FIGS. 16A and 16B. The moving mechanism 165 can use screw/nut systemsor a gears, etc. and can be completely automated and computerized(controlled by computers).

For cleaning process embodiments meat is treated at high energy settings(energy flux densities between 0.20 and 0.80 mJ/mm²) and using 100 to500 pulses per cm³ of meat.

For tenderizing process embodiments meat is treated at high energysettings (energy flux densities between 0.40 and 0.80 mJ/mm²) and using24 to 500 pulses per cm³ of meat.

Cleaning of Industrial, Dirty and Polluted Waters

Referring to FIG. 17, pressure shock waves are used in embodiments ofthe invention for cleaning industrial, dirty or polluted waters. Large,powerful, shock wave applicators 20 are mounted along the cleaning fluidfiltration pipe 170. The applicators 20 are grouped in clusters formedof ten (10) applicators 20 with two opposing groups of five (5)consecutive applicators 20.

Multiple clusters of applicators 20 are mounted along the fluidfiltration pipe 170 in which the fluid that needs cleaning moves at aslow speed, as indicated by the arrow. A first reflectors' cluster 172,a second reflectors' cluster 174 and a third reflectors' cluster 176provide consecutive clusters which are positioned with a rotation of 90degrees relative to the previous cluster. Such embodiment provides easefor access and maintenance.

The number of shocks required for industrial cleaning embodiments is10,000 to 100,000 or more at settings of 20-30 kV (discharge voltage inF₁). In embodiments, energy flux densities of higher than 0.4 mJ/mm² andat frequencies (number of pulses per second) equal or higher than 1 Hzare provided.

Piezoelectric or electromagnetic systems are well-suited for industrialcleaning application to avoid the changing of the electrodes 110 whenthey reach their end of life. The gap between tips in electrohydraulicdevices when wearing to the end of life is large enough to prevent thenormal high voltage discharge between tips and thus preventing theformation of shock waves. Typical electrohydraulic applicators 20 can beused between 20,000 and up to 100,000 possible discharges, before theyrequire the change of the electrodes 110.

FIG. 18 shows an embodiment of the invention including toroidalfiltration with applicators 20A, 20B, 20C and 20D mounted on theapplicators' wheel 180, which has a rotational movement as indicated bythe arrow. The applicators' wheel 180 moves at a calculated low speed,to allow the uniformly deposit of energies into the fluid filtrationpipe 170 in order to achieve the proper cleaning of the industrial,dirty or polluted waters. Multiple toroidal units can be mounted alongthe fluid filtration pipe 170 for improved efficiency and for allowingtargeted cleaning against different types of contaminants, by finetuning each toroidal unit 170 for a special contaminant that needs to beeliminated during cleaning of the industrial, dirty or polluted waters.

FIG. 19 shows an embodiment of the invention including vertical batteryof applicators' clusters 190 composed of toroidal filtration units (FIG.18). To achieve this construction, multiple applicators' wheels 180A,180B, 180C and 180D are grouped and driven around the fluid filtrationpipe 170 through which the fluid that needs filtration moves at lowspeeds to allow the complete filtration process provided by theapplicators 20 present on the multiple applicators' wheels 180A, 180B,180C and 180D. The applicators 20 are constructed with reflectors 22(not shown in FIGS. 17, 18 and 19) that can be an ellipsoid, paraboloid,spheroid, or have any other full rotational shape, which can be used tofocus the shock waves in the treatment/cleaning area.

FIG. 20 shows an embodiment with semi-tubular reflectors 22A and 22B(part of a tube with a parabolic, ellipsoidal or round cross-section),which are used to focus the shock waves generated by the high voltagedischarge across opposing electrodes 110. This construction can createpressure gradients inside the fluid filtration pipe 170 through whichthe industrial, sewer or polluted waters are circulated in the cleaningstation. For this embodiment, an increased number of shocks and/or highenergy settings may be used to compensate for the lost in reflectivearea for reflectors 22A and 22B when compared with normalsemi-ellipsoidal reflectors 22. This supposition is based on the factthat the energy delivered in the focal volume 25 (not shown in FIG. 20)is direct proportional to the reflective area used to focus the pressureshock waves in the treatment/cleaning area. The same construction as theone presented in FIG. 20 can use devices that generate pressure shockwaves using the piezoelectric or electromagnetic principle.

Referring to FIG. 21, pressure shock waves applicators 210A, 210B, 210Cand 210D, such as with ellipsoid geometry, are mounted in series tomaximize the filtration effect. These larger ellipsoids in someembodiments can take 10 L and up to 100 L or more of fluid and allow100% of reflection area for pressure shock waves generated usingelectrodes 110A, 110B, 110C and 110D. The killing of themicro-organisms, bacteria, and the like, can be done by the pressuregradients created inside the applicators 210A, 210B, 210C and 210D.Also, based on the targeted micro-organisms to be killed, the applicator210A can have a different geometry from the applicators 210B, 210C and210D. In fact, different geometries can be found in each applicator210A, 210B, 210C and 210D, which creates a system for filtration thattargets all type of micro-organisms and bacteria found in sewer, dirty,industrial and polluted waters. In other words, in the applicator 210A,a particular type of micro-organism is killed, in the applicator 210Banother type, in the applicator 210C another type and so on. To allowsufficient time for treatment in each applicator (210A, 210B, 210C and210D), a system of filtration pipe valves 212A, 212, 212C and 211D isused to be able to isolate each applicator 210A, 210B, 210C and 210D. Byputting these different types of applicators 210A, 210B, 210C and 210Din series, with each of them designed to target and kill differentmicroorganisms, allows the sewer, dirty, industrial and polluted watersto reach a high level of cleanliness when exiting the treatment plant.This array of ellipsoids can also be combined with other types offiltrations systems using charcoal, ozone, ultraviolet light, and thelike.

The use of multiple clusters with possible redundant action (FIGS. 17,19, 20 and 21) allows the change of electrodes 110 without interruptionof the filtration process when an electrohydraulic approach is used orallows the change of an entire cluster if a failure of the applicators20 may occur when the electrohydraulic, electromagnetic or piezoelectricapproach is used.

Cleaning and Preservation of Food Liquids

Embodiments of the invention used for blood cleaning/sterilization canbe adapted to clean bacteria or other organisms from a variety of otherfluids, such as liquid foods including milk, natural juices, wines, andthe like. This use of pressure shock waves may better preserve the tasteof these fluids, due to the absence of heat or chemicals used inexisting processes employed for cleaning and preservation of foodliquids.

The use of shock waves for commercial cleaning and preservation of foodliquids, in order to be economical needs to sterilize large quantitiesof fluids, which mean that the cleaning/sterilization process must beapplied to the fluids when they flow through a pipe/tube in front of theshock wave applicators 20. Accordingly, embodiments presented in FIGS.1, 3A, 3B, 6A, 6B, 7, 8 and 10 can be applied to accomplish the cleaningand preservation of food liquids such as milk, juices, etc.

For this application, special large reflectors 22 can also beimplemented such as the reflector used for industrial applications (seeFIGS. 17, 18, 19, 20 and 21).

The settings used for commercial cleaning and preservation of foodliquids can use energy flux densities between 0.10 to 0.80 mJ/mm² andusing 100 to 1,500 pulses per cm³ of food liquids.

While the invention has been described with reference to exemplarystructures and methods in some embodiments of the invention, theinvention is not intended to be limited thereto, but to extend tomodifications and improvements within the scope or equivalence of suchclaims to the invention.

What is claimed is:
 1. A method comprising applying shock waves frommultiple and sequential shock wave applicators to industrial pollutedliquids or food liquids in a containment in sufficient amounts to damagea plurality of pathogens, wherein two or more of the sequentialapplicators are different applicators targeting different pathogens. 2.The method of claim 1, wherein the containment is selected from thegroup consisting of a pipe and tube.
 3. The method of claim 1, whereinthe containment is a bag.
 4. The method of claim 1, wherein the shockwaves are focused, unfocused, planar, pseudo-planar or radial.
 5. Themethod of claim 1, further comprising conveying a plurality ofcontainments of industrial polluted liquids or food liquids andsimultaneously applying shock waves to the plurality of containments. 6.The method of claim 1, further comprising staggering the positions ofthe multiple shock wave applicators around the containment.
 7. A methodcomprising receiving industrial polluted liquids or food liquids into areflector portion of a shock wave producing apparatus and applying shockwaves to the industrial polluted liquids or food liquids in a sufficientamount to destroy one or more pathogens present in the liquid.
 8. Themethod of claim 7 further comprising conveying industrial pollutedliquids or food liquids treated with the shock waves to one or moreadditional reflector portions of shock wave producing apparatuses andapplying a sufficient amount of shock waves at each reflector portion todestroy one or more additional pathogens in the industrial liquids orfood liquids.
 9. An apparatus comprising one or more shock waveapplicators operatively coupled to one or more containments containingindustrial polluted liquids or food liquids.
 10. The apparatus of claim9, wherein each shock wave applicator is spatially staggered at adifferent position from an adjacent shock wave applicator.
 11. Anapparatus of claim 9, wherein one or more shock wave applicators arerotating around containment and are operatively coupled to thecontainment.
 12. The apparatus of claim 9, wherein one or more shockwave applicators have reflectors that are ellipsoidal, parabolic,spherical or any full rotational shape that can focus shock waves,reflectors that are operatively coupled to one or more containmentscontaining liquid.
 13. The apparatus of claim 9, wherein one or moreshock wave applicators have semi-tubular reflectors operatively coupledto one or more containments containing liquid.
 14. The apparatus ofclaim 9, wherein the shock wave applicators include one of aelectrohydraulic generator, electromagnetic generator, piezoelectricgenerator or blast generator.
 15. The apparatus of claim 9, furthercomprising a conveyor automatically advancing the containments.
 16. Theapparatus of any of claims 9 through 15, wherein the containment is acircular tube.
 17. The apparatus of any of claims 9 through 15, whereinthe containment is a bag.
 18. The apparatus of any of claims 9 through15, wherein the containment is a conveyance.
 19. The apparatus of claim18, wherein one or more shock wave applicators are operatively coupledto a part of the conveyance that includes at least one valve shuttingoff the flow of fluid within said part of the conveyance.
 20. Theapparatus of claim 17, wherein food liquid is in a sealed and removablebag in a reflector housing with a shock wave applicator operativelycoupled within the housing to the bag.